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Peer reviewedOpen accessSARSCOVID-19

Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities

The Lancet Infectious Diseases·

Rafael Dal-Ré, Linda-Gail Bekker, Christian Gluud, Søren Holm, Vivekanand Jha, Gregory A Poland, Frits R Rosendaal, Brigitte Schwarzer-Daum, Esperança Sevene, Halidou Tinto, Teck Chuan Voo, Nadarajah Sreeharan

DOI
10.1016/s1473-3099(21)00263-2
PMID
34019801
PMCID
PMC8131060
OpenAlex
W3162255312
Study type
Journal article
Publisher
Elsevier BV
Article type
journal-article
Integrity
current

Why this research matters now

The paper is relevant to vaccine development policy, trial continuity, and ethical conduct during rollout. It focuses on equitable access and respectful treatment of participants and host communities rather than on disease surveillance or outcome estimation.

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Structured evidence summary

Research question

How will widespread COVID-19 vaccine rollout affect ongoing and planned phase 2 and 3 vaccine trials, and what trial approaches may be appropriate in different access settings?

Study design

A peer-reviewed journal article that presents a narrative, perspective-style discussion of trial challenges, ethics, and future trial options rather than original participant-level research.

Population and setting

COVID-19 vaccine candidates and their phase 2/3 randomized placebo-controlled trials, with emphasis on high-income countries and on low- and middle-income or resource-poor settings where vaccine access differs.

Main findings

The abstract says vaccine deployment will substantially affect ongoing placebo-controlled trials, especially where broad adult or older-age coverage is expected. It also states that sponsors should consider continuing studies in places with limited vaccine access, and that non-inferiority immunogenicity trials and crossover placebo-controlled designs may be used.

Public-health relevance

The paper is relevant to vaccine development policy, trial continuity, and ethical conduct during rollout. It focuses on equitable access and respectful treatment of participants and host communities rather than on disease surveillance or outcome estimation.

Important limitations

No empirical results are presented in the abstract, and the piece mainly offers recommendations and ethical considerations. This summary is limited to the supplied single-article abstract and metadata, so the full paper is needed for decision-grade interpretation.

GIDS interpretation

This article is straightforward to discover as a 2021 Lancet Infectious Diseases discussion of COVID-19 vaccine trial design and ethics. It should be treated as contextual literature, not as evidence of a live surveillance signal.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 11 auditable classifier relationships to diseases, places, topics, and study design.

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